SMRM18005U Clinical Development and Documentation

Volume 2026/2027
Education

This course is offered in collaboration between University of Copenhagen and Atrium as an obligatory part of the Master of Medicines Regulatory Affairs.

Content

The student will obtain knowledge, skills and competencies within the fields of clinical documentation needed to support global marketing authorisations. This includes:

  • Good Clinical Practice (GCP)

  • Clinical documentation to be created through all phases of clinical development, from first studies in humans, exploratory studies, confirmatory studies and post marketing studies.

  • Overview of regulatory and clinical guidelines and how to apply these during clinical development.

  • Clinical study protocols, reporting study results, benefit-risk assessment, summaries of clinical data and product information (labelling of drugs), which makes up the clinical documentation submitted to health authorities for approval.

  • Clinical regulatory strategy and interaction with health authorities to discuss the clinical development as part of the regulatory process to ensure a successful drug development.

  • The design of early studies, will discuss design of pharmacokinetic and pharmacodynamics studies. The course will discuss how early studies are conducted to best support the design of the confirmatory studies (i.e. phase III trials). The global nature of medicinal product development will be explained and used in model workshops.

  • Selection of the parameters to be investigated in clinical trials are an important part of drug development, and must be based on the objective of the trials. When these items are in place, the design can be outlined and analytical methodologies described.

  • Insight into statistical methodologies and different models for clinical trial design.

  • Clinical Advance Therapy Medicinal Products.

  • Clinical outcome measures.

Upon completion the student will be able to provide regulatory input to the clinical development programme for a product and input to clinical teams. The student will have an overall understanding of what clinical development consist of, and thereby contribute to clinical study teams, investigate the requirements for getting the studies authorised by authorities, interact with global regulators and the requirements for clinical data to be included in the marketing authorisation application, create product information.

Learning Outcome

Upon completion of the course, students are expected to be able to:

Knowledge

  • Explain and identify the principles of clinical development from phase I to IV for both small molecules and biopharmaceuticals
  • Define the required clinical documentation needed to fulfill regulatory requirement for various situations

 

Skills

  • Create, analyse and evaluate a regulatory strategy plan for the clinical development of a new medicinal product
  • Evaluate the possibilities and consequences of the clinical development plan on the desired product information
  • Contribute to plans and proposals with regard to clinical development and documentation
  • Outline and discuss how benefit-risk balance can be handles during development, the the marketing authorisation application and monitored in the post-marketing period

 

Competencies

  • Make decisions with regard to clinical development and documentation necessary for marketing authorisation

  • Review and assess global clinical data and documentation at all levels of the drug development and life cycle reflecting clinical regulators mindset

  • Integrate clinical aspects to ensure that the clinical statements in the product information are sufficiently justified    

The syllabus comprises selected EU, USA and ICH legislation and guidelines. A list of reading material will be distributed electronically. The course participants are expected to study parts of with the syllabus, corresponding to approximately 800 pages.

Lectures and class instructions
Assignments
Self-study of course literature
  • Category
  • Hours
  • Lectures
  • 36
  • Preparation
  • 47
  • Theory exercises
  • 4
  • Exam Preparation
  • 19
  • Exam
  • 4
  • Total
  • 110
Oral
Collective
Continuous feedback during the course of the semester
Credit
4 ECTS
Type of assessment
Home assignment, 4 hours
Type of assessment details
The examination is held on Digital Exam - the online platform for examination at the University of Copenhagen. The examination consist of:
- Descriptive questions
- Essay
Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
No external censorship
Exam period

See exam schedule.

Re-exam

Same as ordinary.

Criteria for exam assesment

To achieve a grade of 12, the student must be able to:

Knowledge

  • Explain and identify the principles of clinical development from phase I to IV for both small molecules and biopharmaceuticals
  • Define the required clinical documentation needed to fulfill regulatory requirement for various situations

 

Skills

  • Create, analyse and evaluate a regulatory strategy plan for the clinical development of a new medicinal product
  • Evaluate the possibilities and consequences of the clinical development plan on the desired product information
  • Outline and discuss how benefit-risk balance can be handles during development, the the marketing authorisation application and monitored in the post-marketing period

 

Competencies

  • Make decisions with regard to clinical development and documentation necessary for marketing authorisation

  • Integrate clinical aspects to ensure that the clinical statements in the product information are sufficiently justified